The supplement industry in the United States has surpassed $37 billion dollars in annual sales and is growing at a rate of 7-10% annually. As the American public becomes more health conscious and informed, more consumers are taking their health into their own hands and using dietary supplements to improve their lives. As the market continues to grow, thousands of different supplement products are released each year, purporting to solve various health issues and improve wellbeing. While supplements can offer immeasurable health benefits, it is important that when labeling products, the claims are not overstated or exaggerated.
One of the benefits of selling supplements in the US is that, when compared to Europe and other parts of the world, American labeling restrictions are much more liberal. Health claims are regulated by the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA.) Each federal agency plays a crucial role in determining dietary supplement labeling requirements.
The FDA is primarily responsible for claims that are made on product labeling, product packaging, inserts and promotional material that accompany the product. The FTC, which regulates media and communications in the US, is responsible for monitoring any claims made in advertisements of products, including internet advertising, catalogs, television and radio ads. These two agencies work closely together to maintain consistency in their policy and implementation.
In 1994, the Dietary Supplements Health and Education Act was passed which established the guidelines for dietary supplement labeling claims for the FDA. This act requires labeling claims to be “truthful, not misleading and substantiated.” Likewise, the FTC has its own legislation under the Enforcement Policy Statement on Food Advertising which applies to supplements as well as food. This act defers to the FDA’s ruling on what is considered to be truthful, not misleading and substantiated and defines a deceptive ad as “one that contains a misrepresentation or omission that is likely to mislead consumers acting reasonable under the circumstances to their detriment.”
Generally, a claim that is made on a dietary supplement must be backed by scientific evidence to be considered for inclusion on a label by the FDA. For FTC requirements, these same requirements must be met, however any claims that can be inferred from the advertising or anything that is implied by claims made must also be truthful and substantiated. It is important to be meticulous in label creation to ensure compliance with these laws. Unless you are well versed in FDA and FTC regulations, it is extremely important to consult with an label consultant to ensure that no label claims may be subject to disciplinary action by these federal agencies.
There have been 120 cases in the last ten years filed by the FTC to challenge the claims made by health supplement companies. In most of these cases, the FTC was successful and manufacturers have had to pay tens of millions of dollars in fines and class action lawsuits for failing to comply with these regulations.
In addition to lawsuits by the FTC, companies have had to defend themselves against class action lawsuits by consumers for products that fail to live up to their claims. A recent high profile class action lawsuit for false advertising was filed against Red Bull, whose slogan was “Red Bull gives you wings.” The complaint claimed that the consumers had been drinking red bull for several years without sprouting wings. While it may seem obvious that an energy drink would not give you wings, the American legal system is set up in such a way that consumers have a right to take advertisements legally. Many other lawsuits have been filed against food and supplement companies for even implying that their product may do something that it does not.
To defend your company and ensure that it does not become a victim of a class action lawsuit or FTC litigation, it is imperative to consult a professional FDA claims consultant, specifically one who is experienced in dietary supplements advertising and labeling regulations.